Cardiac Troponin Assay Classification by Both Clinical and Analytical Performance Characteristics: A Study on Outcome Prediction

Abstract

BACKGROUND Cardiac troponin assays have been classified according to whether they measure the 99th percentile concentration of a healthy reference population with imprecision (expressed as CV) of ≤10%, between 10% and 20%, or >20%. Assays in these categories have been deemed “guideline acceptable,” “clinically usable,” or “not acceptable,” respectively. We compared four widely used “clinically usable” cardiac troponin I (cTnI) assays with an assay designated “not acceptable” for accuracy in predicting the clinical outcome of death. METHODS Blood was collected from 259 men and 249 women, mean (SD) age 68.8 (17.8) and 70.2 (17.8) years, respectively, admitted to the emergency department for suspected myocardial infarction. We measured cTnI by the Access, Architect, i-Stat, Stratus CS, and VIDAS assays. Deaths in this population were recorded over a 31-month period. RESULTS We found VIDAS cTnI assay measurement CVs of 10% and 20% at concentrations of 0.04 and 0.02 μg/L, respectively. Comparing at the 10% CV cutoff concentration, VIDAS cTnI was less sensitive than the Access and Architect assays (P < 0.001) but more sensitive than i-Stat (P < 0.001) and Stratus CS (P < 0.001) in identifying patients with poor outcomes. At the 20% CV cutoff, the VIDAS assay was equivalent to the other assays in identifying patients with poor outcomes. CONCLUSIONS For outcome prediction, the VIDAS cTnI assay was clinically equivalent or superior to other cTnI assays judged to be acceptable from a pure analytical standpoint. Thus, comparison of cardiac troponin assays should consider not only analytical performance, but also clinical performance characteristics.